Chou Denise E, Gross Giti J, Casadei Camilla H, Yugrakh Marianna Shnayderman
Headache Center - Department of Neurology, Columbia University Medical Center, New York, NY, USA.
Neuromodulation. 2017 Oct;20(7):678-683. doi: 10.1111/ner.12623. Epub 2017 Jun 5.
The aim of the current study is to assess the safety and efficacy of external trigeminal nerve stimulation (e-TNS) via a transcutaneous supraorbital stimulator as an acute treatment for migraine attacks.
This was a prospective, open-labeled clinical trial conducted at the Columbia University Headache Center (NY, USA). Thirty patients who were experiencing an acute migraine attack with or without aura were treated with a one-hour session of e-TNS (CEFALY Technology) at the clinic. Pain intensity was scored using a visual analogue scale (VAS) before the treatment, after the one-hour treatment session, and at two hours after treatment initiation. Rescue migraine medication intake was recorded at 2 and 24 hours.
Thirty patients were included in the intention-to-treat analysis. Mean pain intensity was significantly reduced by 57.1% after the one-hour e-TNS treatment (-3.22 ± 2.40; p < 0.001) and by 52.8% at two hours (-2.98 ± 2.31; p < 0.001). No patients took rescue medication within the two-hour observation phase. Within the 24-hour follow-up, 34.6% of patients used a rescue medication. No adverse events or subjective complaints were reported.
The findings from this open-labeled study suggest that transcutaneous supraorbital neurostimulation may be a safe and effective acute treatment for migraine attacks, and merits further study with a double-blind, randomized, sham-controlled trial.
本研究旨在评估经皮眶上刺激器进行的外三叉神经刺激（e-TNS）作为偏头痛发作急性治疗方法的安全性和有效性。
这是一项在美国纽约哥伦比亚大学头痛中心进行的前瞻性、开放标签临床试验。30名正在经历伴有或不伴有先兆的急性偏头痛发作的患者在诊所接受了为期一小时的e-TNS（CEFALY技术）治疗。在治疗前、一小时治疗疗程后以及治疗开始后两小时，使用视觉模拟量表（VAS）对疼痛强度进行评分。记录2小时和24小时时使用的偏头痛急救药物。
30名患者纳入意向性分析。一小时e-TNS治疗后，平均疼痛强度显著降低57.1%（-3.22±2.40；p<0.001），两小时时降低52.8%（-2.98±2.31；p<0.001）。在两小时观察期内，没有患者使用急救药物。在24小时随访中，34.6%的患者使用了急救药物。未报告不良事件或主观不适。
这项开放标签研究的结果表明，经皮眶上神经刺激可能是一种安全有效的偏头痛发作急性治疗方法，值得通过双盲、随机、假对照试验进一步研究。
